How to Overcome Validation Challenges in a Single-Use World

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While the popularity of single-use systems (SUS) is increasing, regulation of SUS supply chains is not. With increased regulatory scrutiny on supply chain security and risk mitigation strategies throughout the development and manufacturing of a therapeutic drug product, end users are scrambling to find ways to ensure the expected level of compliance. The solution? Sharing responsibilities across the entire supply chain. Validation must begin at the component raw material level and continue to final assembly. Primary parties – including drug manufacturers, integrators, component suppliers and regulators – must communicate at unprecedented levels. Conversations should include working through all-aspects of the design, testing, manufacturing and validation of the single-use systems and the drug substances with which they are used for years after approval. This creates a pathway for the industry to share information and to partner at multiple levels.

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